Autologous Transplant for Multiple Myeloma - Full Text View

Sponsored by:	Masonic Cancer Center, University of Minnesota
Information provided by:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00177047

Purpose

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

Condition	Intervention	Phase
Multiple Myeloma	Procedure: Stem Cell Transplant Drug: cyclophosphamide, melphalan Drug: Thalidomide and Dexamethasone	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Autologous Transplantation for Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Cyclophosphamide Thalidomide Dexamethasone acetate Doxiproct plus Melphalan Sarcolysin Dexamethasone Sodium Phosphate Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:

percent of patients achieving complete response (CR) to the total therapy [ Time Frame: Day +100, 6 months and 1 year post transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with disease-free survival without relapse or disease progression. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]
Transplant related mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Incidence of disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Hematologic recovery [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time to relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time to attainment of CR and CR+PR [ Time Frame: During study ] [ Designated as safety issue: No ]
Duration of maintenance treatment [ Time Frame: During study ] [ Designated as safety issue: No ]
Dropout rate from maintenance therapy [ Time Frame: Post transplant phase ] [ Designated as safety issue: No ]
Incidence of toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
Incidence of infections [ Time Frame: During study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	170
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Arm: Experimental Patients receiving peripheral blood stem cell mobilization, chemotherapy and autologous PBSC transplant with high dose melphalan.	Procedure: Stem Cell Transplant As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. Drug: cyclophosphamide, melphalan Cyclophosphamide: 4mg/m2 + Mesna followed by G-CSF 10 ug/kg/d. Melphalan: 200 mg/m2
Maintenance Therapy: Active Comparator Post transplant therapy with thalidomide and dexamethasone.	Drug: Thalidomide and Dexamethasone Thalidomide 200 mg/day po Dexamethasone 40 mg/day po -Days 1-4 and 17-20 for months 1-2, then Days 1-4 for Months 3-12.

Arms

Assigned Interventions

Treatment Arm: Experimental

Patients receiving peripheral blood stem cell mobilization, chemotherapy and autologous PBSC transplant with high dose melphalan.

Procedure: Stem Cell Transplant

As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.

Drug: cyclophosphamide, melphalan

Cyclophosphamide: 4mg/m2 + Mesna followed by G-CSF 10 ug/kg/d. Melphalan: 200 mg/m2

Maintenance Therapy: Active Comparator

Post transplant therapy with thalidomide and dexamethasone.

Drug: Thalidomide and Dexamethasone

Thalidomide 200 mg/day po Dexamethasone 40 mg/day po -Days 1-4 and 17-20 for months 1-2, then Days 1-4 for Months 3-12.

Detailed Description:

Before starting treatment in this study, the BMT doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they will undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection.All patients will receive high-dose melphalan followed by an autologous SCT. Patients will then receive two additional medications (dexamethasone and thalidomide) given by mouth. Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma.
All patients with multiple myeloma requiring therapy.
Patients less than or equal to 70 years of age.
Patients will be eligible after initial therapy in either first complete or partial remission or if no objective response is achieved.
Patients achieving initial response and later disease progression will be eligible after subsequent therapy upon achievement of either complete or partial response.
Patients will be ineligible if they have advanced myeloma refractory to salvage chemotherapy regimens.
To be eligible, patients must have adequate: cardiac function (no active ischemia, left ventricular ejection fraction > 45% by MUGA scan); renal function (creatinine clearance > 40 ml/min); liver function (bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal); adequate pulmonary function (FEV1 AND FVC >50% predicted and DLCO (corrected) > 50% predicted; and Karnofsky performance of > 80%.
Patients must be free of active uncontrolled infection at the time of study entry.
Patients must have adequate hematologic function manifest as hemoglobin > 8 gm/dl (untransfused); WBC > 3000/ml; absolute neutrophil count (ANC) > 1500/ml; and platelets > 100,000/ml (untransfused).
At study entry patients must be > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.
Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 4 weeks following completion of maintenance therapy, will also be excluded from study entry.
Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.
Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177047

Contacts

Contact: Timothy Krepski

612-273-2800

tkrepsk1@fairview.org

Locations

United States, Minnesota
Masonic Cancer Center, University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mukta Arora, M.D. 612-624-5620 arora005@umn.edu

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator:

Mukta Arora, MD

Masonic Cancer Center, University of Minnesota

More Information

No publications provided

Responsible Party:	Masonic Cancer Center, University of Minnesota ( Mukta Arora, MD )
Study ID Numbers:	0312M54569, MT2003-13, 2004LS001
Study First Received:	September 13, 2005
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00177047 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:

stem cell transplantation
chemotherapy
multiple myeloma
autologous

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Melphalan
Thalidomide
Immunologic Factors
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders
Hormones
Anti-Bacterial Agents

Hemorrhagic Disorders
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Multiple Myeloma
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Anti-Infective Agents
Melphalan
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Cyclophosphamide
Hemostatic Disorders

Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Growth Substances

ClinicalTrials.gov processed this record on September 10, 2009